Rosys Models 100 and 200

FDA 510(k) K913664 · Packard Instrument Co., Inc.

Substantially Equivalent

510(k) numberK913664

Submission

Device name
Rosys Models 100 and 200
Applicant
Packard Instrument Co., Inc.
Downers Grove, IL, US
Received
August 16, 1991
Decision date
August 30, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JQW – Station, Pipetting And Diluting, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2750
Specialty
Clinical Chemistry

Other 510(k)s with product code JQW

510(k)DeviceApplicantDecision
K023955BD Viper InstrumentJQW · Traditional Becton, Dickinson & CO06/24/2003SE
K973335Quatro SP Sample Processing Systems (200-499, Inclusive)JQW · Traditional Zenyx Scientific , Ltd.04/30/1998SE
K9801802700 Sample ManagerJQW · Traditional Waters Corporation02/12/1998SE
K970420Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional Pharmacia, Inc.06/30/1997SE
K970616Mini Sampler ProcessorJQW · Traditional Cavro Scientific Instruments, Inc.04/21/1997SE
K962687Gio. de Vita E C. S.R.L.(Gdv) Automatic Washing SystemJQW · Traditional Nichols Institute Diagnostics03/28/1997SE
K962859Mini Sample ProcessorJQW · Traditional Cavro Scientific Instruments, Inc.10/29/1996SE
K961896Microlab 4000, Microlab 4200JQW · Traditional Hamilton Co.08/16/1996SE
K961694ImpactJQW · Traditional Matrix Technologies Corp.06/21/1996SE
K953345GenesisJQW · Traditional Tecan U.S., Inc.11/21/1995SE

More from Tecan U.S., Inc.

510(k)DeviceDecision
K924907Filtermate Universal HarvesterJTC · Traditional 12/01/1992SE
K901808Micromate 196 Model A961960JTC · Traditional 06/20/1990SE
K883749Probe(Tm) Models 700 and 1000JQW · Traditional 11/10/1988SE

Questions and answers

When was Rosys Models 100 and 200 cleared by the FDA?

Rosys Models 100 and 200 (K913664) received a 510(k) decision of Substantially Equivalent on August 30, 1991, 14 days after the submission was received.

What is the product code of K913664?

The FDA product code is JQW – Station, Pipetting And Diluting, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2750.